Clinical trial

A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide

Recruiting now · Phase 2 · 6 countries · Registry ID NCT06897475

Recruiting nowPhase 2Interventional

What this study is about

The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes

Full registry criteria

Inclusion Criteria: * Have type 2 diabetes * Have HbA1c ≥7.5% to ≤10.5% at screening * Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening * Have had a stable body weight for the three months prior to screening * On stable treatment dose of one of the following incretins for at least three months prior to screening: * Injectable semaglutide (1 and 2 milligram (mg)) * Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg) Exclusion Criteria: * Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma * Have a prior or planned surgical treatment for obesity * Have any of the following cardiovascular conditions within three months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure * Have used insulin to control blood glucose within the past year (short-term use allowed) * Current use of prohibited oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the prohibited OAM treatment was discontinued at least 3 months prior to screening * If participant has been on stable doses (for at least three months) of up to three permitted OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study * Have taken any medications or alternative remedies for weight loss within three months prior to screening

Treatments and study arms

LY3457263

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

Change from Baseline in Hemoglobin A1c (HbA1c)Baseline, Week 24

Study locations

60 locations were listed when this page was built. The first 40 are shown.

Centricity Research Brampton Endocrinology🇨🇦 Brampton, Canada
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Harpreet BajajPrincipal Investigator
Ecogene-21🇨🇦 Chicoutimi, Canada
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Daniel GaudetPrincipal Investigator
Winterberry Research Inc.🇨🇦 Hamilton, Canada
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Steven ZizzoPrincipal Investigator
Viacar Recherche Clinique🇨🇦 Longueuil, Canada
Genevieve MathieuPrincipal Investigator
G A Research Associates🇨🇦 Moncton, Canada
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Jocelyn CormierPrincipal Investigator
Bluewater Clinical Research Group Inc.🇨🇦 Sarnia, Canada
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John O'MahonyPrincipal Investigator
Diabetes Heart Research Centre🇨🇦 Toronto, Canada
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Luis NoronhaPrincipal Investigator
Maple Leaf Research🇨🇦 Toronto, Canada
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Graham SmithPrincipal Investigator
Fadia El Boreky Medicine🇨🇦 Waterloo, Canada
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Fadia El BorekyPrincipal Investigator
InnoDiab Forschung Gmbh🇩🇪 Essen, Germany
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut🇩🇪 Leipzig, Germany
Velocity Clinical Research, Leipzig🇩🇪 Leipzig, Germany
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Thomas MuellerPrincipal Investigator
Institut für Diabetesforschung GmbH Münster🇩🇪 Münster, Germany
RED-Institut GmbH🇩🇪 Oldenburg, Germany
Legeartis - Poradnie Specjalistyczne🇵🇱 Bialystok, Poland
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Anna ModzelewskaPrincipal Investigator
Centrum Badan Klinicznych PI-House sp. z o.o.🇵🇱 Gdansk, Poland
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Monika LukaszewiczPrincipal Investigator
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET🇵🇱 Krakow, Poland
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Joanna MirockaPrincipal Investigator
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna🇵🇱 Lodz, Poland
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Malgorzata JozefowskaPrincipal Investigator
Ekamed🇵🇱 Lublin, Poland
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Ewa SkokowskaPrincipal Investigator
Private Practice - Dr. Robert Witek🇵🇱 Tarnów, Poland
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Robert WitekPrincipal Investigator
NBR Polska🇵🇱 Warsaw, Poland
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Katarzyna KlodawskaPrincipal Investigator
Szpital Czerniakowski🇵🇱 Warsaw, Poland
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Olga TurowskaPrincipal Investigator
4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ🇵🇱 Wroclaw, Poland
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Mateusz TabinPrincipal Investigator
Centro de Endocrinologia Alcantara Gonzalez🇵🇷 Bayamón, Puerto Rico
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Altagracia Alcantara-GonzalezPrincipal Investigator
Mgcendo Llc🇵🇷 San Juan, Puerto Rico
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Martha Gomez-CuellarPrincipal Investigator
FutureMeds - Birmingham🇬🇧 Birmingham, United Kingdom
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Tehmina AhmedPrincipal Investigator
Layton Medical Centre🇬🇧 Blackpool, United Kingdom
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Rebecca ClarkPrincipal Investigator
Southmead Hospital🇬🇧 Bristol, United Kingdom
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Georgina RussellPrincipal Investigator
FutureMeds - Liverpool🇬🇧 Bromborough, United Kingdom
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Connor McGladderyPrincipal Investigator
Futuremeds-Newcastle🇬🇧 Newcastle, United Kingdom
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Martin JohnsonPrincipal Investigator
Newquay Health Centre🇬🇧 Newquay, United Kingdom
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Rutesh PatelPrincipal Investigator
George Eliot Hospital🇬🇧 Nuneaton, United Kingdom
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Ponnusamy SaravananPrincipal Investigator
The Adam Practice🇬🇧 Poole, United Kingdom
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Patrick MoorePrincipal Investigator
Clifton Medical Centre🇬🇧 Rotherham, United Kingdom
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Matthew CapehornPrincipal Investigator
Rame Group Practice🇬🇧 Torpoint, United Kingdom
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Susan KeastPrincipal Investigator
Investigators Research Group🇺🇸 Brownsburg, Indiana, United States
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Kenneth MaynardPrincipal Investigator
Providence Health Partners-Center for Clinical Research🇺🇸 Dayton, Ohio, United States
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Paul OpsahlPrincipal Investigator
Juno Research🇺🇸 Houston, Texas, United States
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Damaris VegaPrincipal Investigator
Balanced Life Health Care Solutions/SKYCRNG🇺🇸 Lawrenceville, Georgia, United States
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Nadia Cameron, MDPrincipal Investigator
Physicians Research Associates🇺🇸 Lawrenceville, Georgia, United States
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Ola OdugbesanPrincipal Investigator